ISO 11137-2:2013
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
This standard has an identical version adopted as a Singapore Standard. The adopted Singapore version has the same content as this version and is available at a significantly lower cost. To view and / or purchase the adopted Singapore Version, click here .
OVERVIEW
ISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10-6. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2013 |
| No. of Pages | 68 |
| ICS Classification | 11.080.01 Sterilization and disinfection in general |
| Committee | ISO/TC 198 |
| Available for Purchase | For sale in Singapore only |
| Adoption | ISO |